Category Archives: Delivery of Healthcare

Diabetes Updates – New Diagnostics, Increasing Rates, and Implications for Health Reform, CER, etc.

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Changes in the diagnosis and treatment of diabetes is a great example for understanding how healthcare delivery constantly evolves based upon new discoveries.  And the history of these changes may help illuminate some thinking about health reform and the development and use of comparative effectiveness research (CER).

First, a little background on diabetes.

Diabetes Background
Diabetes mellitus (or “sugar diabetes”) occurs when the body has problems regulating the level of sugar (specifically glucose) in the blood.  This can be because the body’s pancreas doesn’t produce enough insulin, or for some reason the person’s organs become resistant to the actions of the insulin that is present – or sometimes both occur simultaneously.  Impaired control of glucose means that the levels get too high, which produces problems in the eyes, (leading to blindness), in the kidney, (leading to kidney failure), and in the small blood vessels elsewhere in the body, which can lead to nerve damage and low oxygen delivery to the extremities – particularly the legs and feet, (leading to amputations).

In olden times, diabetes could be diagnosed by sugar in the urine.  (Medical lore says this was done by taste….)  However, until insulin was discovered in 1921 there were no therapies for severe insulin deficiency.  And even once insulin became available, sugar in the urine was still the way diabetes was diagnosed and monitored – usually with a dipstick that changed color depending on the sugar concentration.

It wasn’t until the 1960s that measuring blood glucose levels became possible – and only then in the doctors’ offices because the machines were large and expensive.  In the 1980s machines small and cheap enough for patients to monitor their blood sugar levels at home became available.  This enabled patients to start adjusting their own insulin dosages based upon their blood sugar levels.  (Before this it was too dangerous for patients to significantly alter their insulin dosages because while too little insulin leads to too high sugar levels causing long-term damage, too much insulin can drop sugar levels too low and lead to confusion, coma and death.)

In more recent years it was discovered that keeping diabetics’ sugar levels near normal could prevent essentially all the adverse consequences of diabetes, i.e. blindness, renal failure and amputations. But doing this based upon finger-stick blood sugar levels even 3 and 4 times a day was tricky – and those were just single data points.  So in the mid 1970s it was proposed that monitoring the amount of hemoglobin in the blood that had combined with glucose would give a measure of the average blood sugar level for the 2-3 month life of the red blood cells.  (It was known that glucose irreversibly connects to the hemoglobin in red blood cells in a way that directly correlates to the blood sugar level.)  This test, known as “glycosylated hemoglobin, (or HbA1C, or simply A1C), has been increasingly used over the past few decades to monitor diabetics and adjust their treatments, with the goal to keep A1C levels below 7%, since the level in people without diabetes is 4-6%.

Care Lags Discovery and Development of Innovations
Despite improved ability to monitor diabetes, it is still under diagnosed, and poorly managed.  It is estimated that there are about 6 million people in the US who have diabetes, but don’t know it – which is about 25% of all people with diabetes.  And in 2003-2004, only about 57% of people with diabetes had A1C levels <7%.  (The medical and lost productivity costs for all people with diabetes may be approaching $200 Billion.)

And the prevalence of diabetes is increasing – and with it so are the costs of treating people with diabetes. Last year I wrote about this, and now the CDC has updated information showing the continuing growth in the number of people in the US diagnosed with diabetes:

Increasing Rate Diabetes in the US 1980-2006
Source: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm

The treatment of diabetes has also changed.  After insulin was discovered, different forms and modifications where developed to change how quickly it acted, and beef and pork sources have been replaced with biotech “human” insulins grown in bacterial cultures. Many different types of non-insulin treatments for diabetes have also been developed – these act primarily by increasing insulin production from the pancreas or the action of the insulin in the body.

Which brings us back to the A1C test.  An International Expert Committee from the American Diabetes Association is now recommending that the A1C test be used to diagnose diabetes.  This would replace (or supplement) the traditional fasting blood glucose diagnostic test, and the A1C test would still be used for twice yearly monitoring of the adequacy of treatment for people with diabetes.

These developments in diagnosis and treatment have progressed in tandem – each leveraging off the knowledge gained from the other – with the A1C test being part of the continuing evolution of tests for diagnosing diabetes.  For example, the fasting blood glucose level for diagnosing diabetes has changed over the years.  It was originally set at 140mg/dl in 1979, and then lowered to126 in 1997, when it was also decided that a level between 110-126 should be considered pre-diabetic, or “impaired fasting glucose.” And in 2003 the lower bound for “prediabetes” was lowered to 100.

Why A1C Now?
While A1C testing has been used for years, there have been problems in standardizing the measurement. (This is discussed in the ADA paper linked to above.) But now A1C measurement inconsistencies, (which occur for all lab tests), have been narrowed sufficiently so that the ADA committee is recommending that an A1C level of >6.5% be used to diagnose diabetes, (for patients who are not pregnant and do not have hemoglobin abnormalities – these can change HbA1C levels significantly), and that people with A1C levels >6.0% and <6.5% be considered to have “subdiabetic hyperglycemia” because they have a significant risk of progressing to diabetes.

So Back to Health Reform and CER – The Challenges Ahead
The challenges ahead are to make sure that we continue to utilize future discoveries in a timely and intelligent way. Which finally brings us to health reform and CER. Health reform that expands insurance coverage should dramatically improve the diagnosis and treatment of people with diabetes – which should also help control other healthcare and societal costs because poorly controlled diabetes leads to many other costly problems.  However, immediate cost pressures present barriers to using the best diagnostic and therapeutic interventions.

Comparative effectiveness research is supposed to provide information about the best interventions, but as has been seen with advancements in diabetes, what is best often changes in progressive leaps based upon new discoveries.  And one of the limitations of CER, (and all research for that matter), is that it takes time to do the work and analyze the results.  Therefore, research really provides information about what was the best when the research started – which could have been several years before the results are known and disseminated.  And this time lag effect can be even longer when the research is based upon previously published studies or analyses of clinical records.

The lesson here is that while CER and similar research can provide very important and useful information, it must be put into the proper historical and clinical contexts.  What was state-of-the-art when the research protocols were developed may be 2, 3, 4 or more years out of date when the data is analyzed.  This reality needs to be considered when such information is used for coverage and reimbursement, and decisions about health delivery and financing system redesign.

I am confident that most insurers are not paying for A1C tests to screen people for diabetes – and that it will likely take a year or more for even the most progressive insurers to do so…. but they eventually will.  Which raises the question, what did they gain by waiting?  And what did they, (and the patients), lose?

Addendum: The hospital lab my doctor uses charges $59 for a HbA1C test.  So assuming that price doesn’t come down if more people are getting the test, the calculation needs to be made as to what is the ROI for using HbA1C as a screening test?  And the CER questions are how to identify people who would most likely benefit from HbA1C screening, and how to determine how frequently the screening should be done?

Healthcare Policy and Healthcare Politics – Summer 2009

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As Congressional Committees appear to be steadily walking towards the starting line for considering health care reform legislation next week, I’ve been thinking about various healthcare policy and political events and activities that will influence the substance and process for these efforts over the coming months – and perhaps years.

Because a complete examination of all the important events and documents from the last several months and years would be too long for a single post, summarized below are some of my observations and thoughts about the meaning of 5 touchstones that people will likely reference in the coming months as part of the health reform dialogue:

  1. Massachusetts’ health coverage and reform initiative
  2. The Senate Finance Committee’s 3 Policy Option Papers
  3. Frank Luntz’s health care talking point paper for Republicans
  4. The May 11th letter from 6 national groups to President Obama
  5. The Democratic Party’s development of Organizing for America

As discussed below, each of these activities and documents has dual (or dueling) policy and political goals, (i.e. changing policy to improve the healthcare system, or designed to win political points), that may be aligned or in conflict.

1. Massachusetts Health Coverage and Reform Initiative

  • The original legislation was a political compromise that included:
    • The use of private insurance to expand coverage
    • An individual mandate
    • An employer penalty for not having all their workers insured (a.k.a. play or pay)
  • Single payer is discussed and supported in Massachusetts, but wasn’t part of the state’s health reform initiative
  • The state’s Commonwealth Connector insurance exchange doesn’t include a public plan choice/option
  • Despite not being a single payer system, nor including a public insurance plan option, the state’s initiative expanded insurance coverage to more than 97%
  • With the success of increased insurance coverage has come expanded demand for primary care services and subsequently longer waiting times for those services
  • The state is looking at various processes for controlling costs as a second outcome to be achieved
  • The state’s ability to control health care spending will likely require Federal regulatory and/or legislative cooperation from programs such as Medicare, Medicaid, and ERISA

2. Senate Finance Committee’s Policy Option Papers

  • Between April 29 and May 20th the Senate Finance Committee released 3 papers describing options for health delivery system transformation, expanding coverage, and cost savings and revenue raising.  (The Committee also held hearings on these papers.)
  • The overarching theme in these papers is transparency and accountability
  • Several issues are notable for their absence from the papers:
    • Discussion of a single payer option for overall reform
    • Cost savings estimates for a public plan option
    • Changing or repealling Medicare Part D’s “Non-Interference” provisions as a source of revenue
  • The only mention of ERISA is in the savings and revenues paper – It is not discussed in the context of health delivery transformation or expanding coverage
  • Medicare’s physician payment formula problem is discussed, and the cost of a 10 year freeze is cited as $285 billion
  • Accountable care organizations (ACOs) and care coordination are frequently mentioned goals, but the papers generally only propose demonstrations or pilot projects rather than definitive programmatic changes

3. Frank Luntz’s “The Language of Healthcare 2009″ Paper

  • This paper advises Republicans how to talk about healthcare in a purely political context.  It doesn’t substantially address policy aspects of health reform issues, and it is all about winning as many Republican and moderate hearts without considering their minds
  • The goal of Luntz’s talking points are to paint Democrats’ health reform plans as leading to government bureaucrats making health care decisions, rationing of care, and denying access to necessary care
  • The paper builds upon the premise that patient-doctor relationships are good and that government bureaucrats are bad.  It specifically states that the Democrat’s “government takeover” of the healthcare system will result in a bureaucrat putting “himself between you and your doctor, denying you what you need”
  • Luntz’s paper leverages people’s fear about loss of control and autonomy, but it doesn’t address people’s immediate and real concerns that high costs are denying people access to the insurance or care they need – in effect rationing based upon the ability to pay for the ~49 million people in the US without health insurance and the millions more who are underinsured because they can’t afford their co-payments or deductibles

4. May 11th Letter to the President from 6 National Groups

  • The 2 page letter from AdvaMed, AHA, AHIP, AMA, PhRMA, and SEIU is mostly political posturing
  • The letter uses all the right phrases:
    • “access to affordable high quality health care”
    • “transform the health care system”
    • “transparency that supports effective markets”
    • “aligning quality and efficiency incentives”
    • “encouraging coordination of care”
    • “adherence to evidence-based best practices”
  • Karen Ignagni deserves big kudos for pulling together the other 5 groups and getting agreement for the letter, but herding their collective seagull-like members into agreement for specific reform proposals – other than an individual mandate to have insurance – will be a much bigger challenge, as Paul Krugman recently discussed in his recent column
  • Getting all these groups to the same side of the same table is a success of process, but not a successful outcome.  A collective meeting of minds of similar groups was necessary for the enactment and implementation of Massachusetts’ coverage expansion law, and it is also being used in the state’s efforts to control the growth of healthcare spending

5. Organizing for America (OFA)

  • The Democratic National Committee (DNC) is working to develop OFA as a program to capture the grassroots energy and organization of the Obama campaign, with the goal of using OFA to support the Administration’s policy initiatives – the first of which is healthcare, to be followed by energy and education
  • On May 16th I attended an OFA-MA organizing meeting – along with about 500 other people from around the state. The open Q&A and my discussions with individuals made it clear that single payer has strong and wide support in this group, despite candidate and President Obama’s consistent message that if we were designing a system from scratch, single payer would be an attractive option, but given our immediate needs and problems, other significant targeted changes are needed to improve people’s lives by increasing coverage and controlling costs quickly and effectively.  (Not too mention that such targeted changes face much lower political hurdles than a single payer reform option.)
  • OFA is gearing up for Congress’ consideration of heatlhcare legislation by organizing house parties across the country on June 6th to gather individual stories and prepare the OFA grassroots rooters to engage their elected representatives, the media, and whoever else they can reach on healthcare reform

Conclusions

  1. How to pay for health reform still hasn’t been determined, and this summer Congress will also have to “fix” Medicare physician fee schedule – which will cost about $20 billion/year
  2. The most difficult aspects of health reform, (outside of paying for it), are how to do risk/severity adjustments for payments and quality analyses, how to measure the success of initiatives using a blend of process and outcome measures, and how to estimate, (or “score”), costs or savings from many of these initiatives – particularly for those that involve behavior change, disease prevention or health promotion, or are expected to act synergistically with other initiatives, such as patient-centered medical homes or other care coordination intensive models
  3. Agreement on principles is easy, but agreeing to specific proposals is difficult because one person’s waste is another person’s income
  4. ERISA is the 500 pound gorilla-issue sleeping in the corner
  5. Massachusetts is different than most other parts of the country – both in terms of policy and politics – but its experience presents valuable lessons about the process for bringing stakeholders to the same table and for creating a health insurance exchange with low-income subsidies
  6. Politics will be required to enact national health reform legislation, but the specific policies put into new laws will be important for determining their success or failure upon implementation, because a disconnect between politics and policy can result in legislation that produces outcomes different from what are intended.  For example, the Balanced Budget Act of 1997 changed the Medicare managed care program, (and renamed it Medicare+Choice), with the goal of expanding managed care options for people enrolled in Medicare.  However, following BBA ’97 Medicare+Choice options decreased rather than increased.  In addition, success or failure of one initiative sets the environment for the next, e.g. the failure of BA’97 to expand Medicare+Choice enrollment created the context for the development of the Medicare Part D prescription drug program in 2003.  Similarly, the success of Massachusetts’ expansion coverage law has enabled the state to explore options for controlling overall health spending as a next step – something that would not have been possible if the expansion law had failed or been derailed…… as it had been twice before.

Footsteps


People in Health Reform & Transformation

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The importance of the “people factor” in improving the quality and efficiency of healthcare is well understood by experts in health information technology (HIT) and healthcare delivery transformation.  In estimating the time and cost for implementing new technologies or processes, they appreciate how behavior change and technology adoption are very time consuming and expensive – factors that are often glossed over in policy discussions.

David Brooks’ recent Op-Ed in the New York Times about the personality traits of CEOs leading successful companies sheds some light on the people factors in health reform.  Contrary to a lot of the common wisdom about the importance of good personal connections with coworkers for success in the corporate world, Brooks cites information that the most important factors for successful CEOs are “execution and organizational skills. The traits that correlated most powerfully with success were attention to detail, persistence, efficiency, analytic thoroughness and the ability to work long hours.”

He goes on to state that what produces effective CEOs are “emotional stability and, most of all, conscientiousness — which means being dependable, making plans and following through on them.”

In the medical world, this would describe most surgeons, but the difference between the corporate and medical worlds is that CEOs have greater direct control over their people and organizations than do the leaders of health delivery organizations like hospitals or clinics, which rely on the performance of many different professionals and skilled staff who function quite independently, such as doctors, nurses, and many types of therapists.  Thus, while “being a good listener, a good team builder, an enthusiastic colleague, a great communicator [does] not seem to be very important when it comes to leading successful companies,” in the clinical world, these traits are very important.

Brooks’ comment that, “business leaders tend to perform poorly in Washington, while political leaders possess precisely those talents — charisma, charm, personal skills — that are of such limited value when it comes to corporate execution,” correlates very well with my observations of senior corporate managers, politicians and clinicians.  I have seen business leaders who are successful in working the political circuit but have struggling corporate organizations, and politicians who enter the business world – often as leaders of lobbying or policy organizations in Washington DC – whose operations are chaotic and inefficient.

However, there are a wide variety or organizations in the healthcare universe’s 4 spheres, and the leadership qualities best suited for increasing quality and efficiency depend upon the sphere the organization is operating in, the type of organization, and the local culture.  For example, leading a biotech, medical device, diagnostic, HIT, or pharmaceutical company requires the type of hyper-focused “boring” CEO described in Brook’s column.  But successfully leading a hospital, clinic, or private medical office requires someone who has relatively stronger people skills.  And someplace in the middle would be the leadership of health plans which have to bridge the business and clinical worlds, and leaders of government agencies which have to straddle the policy and political arenas.

Keeping the importance of the people factor in mind while developing health reform and transformation proposals will help create realistic expectations and time lines – both for the actual transformation of care delivery and the ability to achieve cost savings.  For example, as CBO noted a year ago – and I’ve previously commented on – the ability of health information technology to achieve cost savings is dependent upon how those technologies actually change behaviors of clinicians, patients, and others – a process which is very time consuming and expensive.

Communicating with Clinicians to Improve Quality

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At a recent public forum on improving quality and value in healthcare, an audience member asked how can patients know if the treatment or diagnostic test their clinician is recommending is really the best thing for them.  This reminded me that the Agency for Healthcare Research and Policy (AHRQ), recently ppublished a two page tip sheet to help patients talk to their doctors and a web-page that helps people create a set of questions customized for their individual healthcare needs and situations.

While these are obviously useful tools, I realized that emphasizing patient-clinician communications is now more important than ever because of the growing trend toward “consumer directed healthcare” and “patient empowerment.”  While these types of activities and insurance product may be able to reduce costs by incentivizing people to use less healthcare, how they effect quality is still uncertain.  In addition, the enormous amount information available on the internet is making people well armed with data and facts, but not necessarily with knowledge.  Even with a lot of facts and data, patients are much better off having another person, (i.e., a trained clinician), integrate all the information about their individual situation and present a complete perspective and set of recommendations.  (This is why it is generally not appropriate for physicians to treat themselves or family members, i.e. because they cannot be both the patient – or family member – and provide an impartial and objective analysis.)

Asking Questions is Key for Communications and Quality Improvement
The AHRQ materials are valuable for improving the quality of care because patients may find themselves overwhelmed in a medical office, and forget to ask the right questions – particularly when faced with a new diagnosis or presented with a set of recommendations for treatment of an existing condition.  Coming to the medical office with a set of written questions will help remind the patient what questions they want to ask, and help promote a conversation with the clinician about the patient’s needs and desires. Clinicians are generally much more receptive to patients who ask questions than to those who just present opinions, requests, or demands about their treatment.

AHRQ’s “Talking with Your Doctor” tip sheet, has two key messages for both policy makers and patients:

  • Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care – and to have better results.
  • Write down your questions before your visit. List the most important ones first to make sure they get asked and answered.

Checking for the Checklist
AHRQ’s web-page for creating customized question lists is a valuable resource not just for preparing to talk with clinicians, but also for choosing health plans, hospitals, long-term care facilities – as well as clinicians.  While the list of suggested questions AHRQ is good, one item that I’d add is, “Does the hospital require the use of surgical checklists?”  (FYI – I’ve written about how such checklists have been shown to reduce errors and improve quality, and I’ve suggested that patients ask their surgeons and hospitals if they use them – and if not, why not?)

And apparently I’m not alone in promoting greater use of checklists in hospitals.  I recently heard that Health Care for All here in Massachusetts is pushing for legislation to require hospitals to use such checklists.  I applaud their efforts to highlight this quality improving measure, but also want to note that there are arguments on both sides for whether legislation is the best route to improve quality of care at all hospitals.  For example, how specific do we want laws to be in listing what hospitals and doctors are required to do, since laws can be difficult and time consumer to change?  Conversely, how quickly and completely will hospitals and doctors change their practices if they are not compelled to do so by new laws? And are their other mechanisms besides laws to make these changes faster and more completely?

Questions are the Answer
Whatever routes are used to improve quality of healthcare, (e.g. legislation, patient empowerment, financial incentive, peer pressure, etc.), it’s clear that patients, advocates, policy makers, and others need to continue asking thoughtful and focused questions.  As the website name for AHRQ’s customized questions list states, “Questions are the Answer.”

Improving Cancer Care in Medicare

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This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA).  The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature.  This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited.  That is, under current law, for non-cancer illnesses, Medicare Part D plans can still limit coverage to only the off-label uses listed in the standard compendia.

American Medical News ReachMD Interview May 5, 2009 - Off Label Coverage by Medicare Part D Plans
American Medical News ReachMD Interview May 5, 2009:
Off Label Coverage by Medicare Part D Plans

I had recommended that the MIPAA change go beyond cancer to include serious or life-threatening conditions – terminology that is somewhat imprecise, but widely recognized, including by the FDA. However, I suspect that because of cost concerns, this broader expansion of off-label coverage was not included in MIPPA.  I find this interesting for two reasons.  First, in these times of record government spending, even MIPPA’s limited coverage expansion for off-label cancer treatments raised some concerns about cost increases – which I wrote about in January.  And second, that restricting coverage of treatments in this way seems philosophically opposite to the intended benefits of Comparative Effectiveness Research – which is all about using the best research findings to improve the quality of care.  Of course, with the size of our health care system, I’m sure this won’t be the last time the left and right hands are not perfectly in sync.

Juggling Balls

Business Perspectives on Comparative Effectiveness Research

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Comparative effectiveness research continues to be a hot health policy issue for many companies and stakeholders, in part, because they’re concerned that CER information will be used to deny access to innovations because of cost.

I recently talked with Jeff Sandman, CEO of Hyde Park Communications, about how healthcare companies should productively approach CER issues, and how quickly CER would lead to dramatic changes in the healthcare system.  (See part of our conversation below.)

There will certainly be more reports, seminars, meetings and Congressional hearings about CER as the $1.1 Billion in ARRA funding for CER is distributed, and the results of that research begins to roll in. I’ve written about CER in the past, (see here and here), and expect to continue writing and talking about it in the future – and I would be very interested to hear anyone else’s perspectives on this issue and how they think it will impact the transformation of healthcare.

30% Off Health Care

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I get lots of emails.  Some are interesting.  Others are Spam – such as the one offering to double my gas mileage by showing me how to run my car on water.  (Don’t they know that cars run on air not water!!!!!)

And last week I got one promising to cut health care expenses by 30%.  Not just my health care expenses, but the entire countries spending on health care. (See their promotional coupon below.)

30% off health care coupon

As you can see, this is really a call for people to support a public plan as part of health reform.  This is a great message and marketing gimmick, but the problem is that nobody has agreed on the definition of a “public health insurance option.”  For example, Nancy-Ann Deparle, (Director of the White House Office of Health Reform), has said that a public plan could be like the Federal Employees Health Benefits Plan, which offers government employees a range of private insurance and managed care options.  But I haven’t heard anyone suggest that the FEHBP has reduced costs or premiums by 30%.

The 30% figure probably came from the Lewin Group’s analysis of how many people might go into a public plan option and how much it could save.  Their report put some numbers around the obvious conclusions that the lower the prices the government plan paid for healthcare products and services, the less it would cost and the number of people going into such a plan would be greater. They specifically found that, “If Medicare payment levels are used in the public plan, premiums would be UP TO 30 percent less than premiums for comparable private coverage. [emphasis added.]

Another factor that could influence the structure of a public plan, (if one is created in this thing we’re calling health reform), is that paying for healthcare care based upon each service, (a.k.a. fee-for-service), is being widely blamed as a prime cause for healthcare inflation.  And many payers – including the state of Massachusetts – are looking for other ways to pay for healthcare, such as making payments based upon quality or complete episodes of care….basically anything but fee-for-service (FFS).  Thus, the long term viability and cost savings of a public plan based upon Medicare-like FFS reimbursements is questionable. However, creating a public plan based on payment systems that aren’t yet widely used – such as global payments – also seems problematic.  And going the route of Massachusetts, (whose Connector is very much like FEHBP), seems too simple and probably won’t produce significant near term savings.

All this leaves me wondering what will happen, and if there are fourth, fifth, or sixth options?

Comparative Effectiveness, Efficacy, Evidence Based Medicine, P4P, etc…

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Comparative Effectiveness Research (CER) is being talked about more and more as a fulcrum for controlling healthcare costs.  For example:

  • The Congressional Budget Office issued a report on CER in December 2007 and has highlighted it in more recent analyses and reports about health reform options
  • The ARRA legislation included $1.1 Billion for CER
  • ARRA included language for the IOM Committee on Comparative Effectiveness Research Priorities to provide a report by June 30, 2009 about how to spend the $400 million allocated to HHS for CER.

All this discussion has kept me thinking about how CER will be done, how the results from this research will actually be used to improve quality and reduce costs, and what are the scope of healthcare issues that CER is, will, or should be applied to help improving.

While understanding what works best in healthcare is certainly a worthy goal, this is far from a simple task.  Some of the factors that complicate research to compare the effectiveness of various treatment options are:

  • Gold-standard double-blinded trials for clinical research provide information about efficacy – which is different than effectiveness.
  • Observational research can provide information about real world effectiveness, but the information from this type of research can be flawed by problems in the data – including selection biases and other conclusion skewing factors.
  • Both these types of research methodologies inherently have a lag between the time the research project starts and the time the data is analyzed and conclusions developed.   This time lag is often several years, during which new treatment options will likely have been developed.  Thus, CER really is only answering questions about the most effective treatment options when the study began, not when its conclusions are presented.
  • There is also considerable controversy about what factors to compare in CER projects.  That is, should only clinical outcomes be compared, or should costs be a factor?  And if cost is a factor, how are indirect costs, such as diagnostic testing, office visits, patient’s time, etc., included?  And how is quality of life valued?  (Some CER analyses report results according to Quality Adjusted Life Years).
  • And of course people interested in biopharma and medical device innovations are concerned that CER will be used not just to inform clinicians and patients, but to justify coverage and payment decisions which will impact R&D in therapeutic areas where reimbursement for innovative products is denied or limited.

All of these factors point towards larger issues of how to ensure that medical practice is maximizing knowledge to optimize clinical care for the good of the patient and society.  In some cases, this is termed Evidence Based Medicine (EBM).  In theory CER should support good EBM ASAP.  And from what President Obama has said, he wants this done PDQ.

Health System CER & Evidence-Based Interventions
While all these challenges for CER are ongoing, there also seems to be opportunities for applying the principles of CER and EBM to more system wide properties of the US healthcare system to increase value and efficiency.  For example – and I hope I’m not beating a too tired horse here – but the surgical checklist (and similar quality improving activities) have been shown to increase quality and reduce costly events, but not all hospitals and clinicians are using them.  Therefore, how about research to compare the effectiveness of hospitals (or surgeons, etc.) that use and don’t use such practices?  Some people might say that we don’t need this research since the value of these practices is already known, but perhaps focused research highlighting this information will serve as a big push to get the laggards on-board.

Similarly, CER type analyses could be applied to Medical Homes to determine what characteristics and capabilities of Medical Home medical practices make them better at improving the quality of patient care and controlling overall spending.  In particular, there might be specific features of Medical Homes that would be most important for diabetics, and others for patients with CHF, etc.  And currently NCQA’s 3 tiers of Medical Homes build upon each other, but don’t permit greater granularity nor do they distinguish between potentail patient populations. This research might be complicated, but with initiatives such as Medical Homes being proposed as a way to redesign and reconfigure outpatient care in the United States, more focused research beyond the existing and planned demonstrations and pilot projects might be very worthwhile expenditures.

P4P for Cost Containment
Another big push for cost containment in health reform is pay-for-performance (a.k.a. P4P).  While the knowledge gained from CER could certainly be fed into P4P practices, P4P itself has some controversy about how well it does or does not work to change behaviors to improve quality and reduce costs. At a breakout session about P4P at a conference on Friday led by Bob Galvin, MD (GE’s Director of Global Healthcare), I stated that two basic criteria that P4P interventions need to be successful are:

  1. The group effected needs to be small enough that each individual feels that changing their actions will effect their compensation, i.e., a group of 500 clinicians is too large, but it most likely can be larger than 5.
  2. The information about how the group or the individual is doing towards any P4P goals is delivered often enough to provide timely feedback, i.e. once a year is not frequent enough, perhaps quarterly is OK, and monthly would be great.

Dr. Galvin pointed out that the size of the P4P incentives also needs to be significant, i.e. it can’t max out at $100 per clinician.  And another participant noted that the P4P measures need to be controllable in some way by the clinician.  For example, while patients’ seat belt use might be somewhat influenced by clinicians’ reminders and admonishments, clinicians are much more able to see that their diabetic patients are getting regular HbA1C testing, eye exams, and appropriate immunizations.

Coming Full Circle From CER to P4P
18 years ago I coauthored a book chapter about the structure of bonus pools and other P4P-type incentives for physicians in nascent managed care organizations. Unfortunately, in the early 1990s, there weren’t robust information systems to provide data about “performance” for these P4P systems to be effectively implemented.  Perhaps now – and in the future – as health IT matures and become well integrated into healthcare delivery, better data will be available and P4P can be productive for clinicians, patients and society.

To help make that potential a more likely reality, perhaps some of the CER efforts could also be directed toward determining how to best structure and implement P4P programs to maximally change clinician (and possibly patient) behaviors to better utilize information about what is already known to work best in medical care.  And then these same P4P interventions would be in place and prepared to use the new knowledge that will come out of the expanded CER programs starting this year – and which will hopefully enable us to dramatically improve medical care and the medical system in the future.

Quality, Checklists, Patient Education, the TV Show ER, and Comparative Effectiveness

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In case you missed it last week, amidst all the returning stars for one of the final episodes of the TV show ER, there was a dramatic Operating Room scene where Dr. Benton (played by Eric Lasalle) is “observing” the kidney transplant of Dr. John Carter (played by Noah Wyle), because as we see, the transplant surgeon is a very coarse and roughshod individual.  The significance of the scene is that as the surgery is about to begin, Dr. Benton pulls out his  pre-surgical checklist and browbeats the transplant surgeon into going through it – during which the nurses note their concern that they don’t have reperfusion solution in the OR, so they go and get some as the surgery starts.  Since this is TV, this turns out to be crucial when the kidney develops a clot, and a delay in getting the solution could have meant the difference between success and failure of the kidney transplant.  (Note – this connection may be taking a bit of artistic/entertainment license, but the point is that delays in having needed equipment or supplies can effect the quality of care.)

While Atul Gawande has written about such checklists in the New Yorker magazine, perhaps this fictional medical TV drama will help more people understand the importance of such quality improving steps, and even encourage them to start asking their doctors and hospitals if they use these types of quality improving checklists….. And if not, why not?

Physicians’ Perspectives
The next day I was talking with a physician friend, and mentioned the episode.  I was both bemused and concerned that he said all the staff is his outpatient clinic were talking about the returning stars, and nobody had mentioned the checklist scene.  We then talked about how physicians often think the way they do things is the best, yet generally lack any data to show how well they are really doing.  We agreed that physicians have traditionally viewed checklist etc,  as “cookbook” medicine that took away their autonomy.  I pointed out that while this might be true on a very microscopic level, by systematizing what they routinely do in a way that improves outcomes, they can then focus their knowledge and skill onto the unique aspects of each patient’s needs.

This is similar to what a basic science researcher once told me about golf. (He is a near scratch golfer.)  He told me that since the game has so many variables, more of them that you can eliminate the better you will perform.  For example, always playing with the same clubs is obvious, but for the same reason you should also play with the same brand and type of ball and glove, and develop standard pregame and preshot routines.  That way, you can focus on the variables you can’t control, such as the weather, the wind, the lie of the ball, etc.  The same is true for clinical care.  By standardizing the routine and repetitive actions according to protocols that have been shown to work well, clinicians can focus on what is variable and important.  (This is also why I always keep the same set of things in one pocket: keys, chapstick, two blue pens, one red pen, and my migraine medicine. And why I always leave my keys, wallet, sunglasses, etc. at same place at home.  That way I never have to spend time looking for things I use all the time.)

Collecting and analyzing data about individual physician performance is really going to be the next significant development in health reform and quality improvement.  And it is already occurring in some places – such as within the health benefits program for Massachusetts government employees.

This data collection, analysis and reporting will be similar to what is being done for hospitals, and thus will follow the trend of taking technologies out of the hospital and using them in the outpatient world.  However, as with all healthcare data analysis. the major challenge will be in adequately adjusting for patient differences so that physician performance is based upon realistically achievable outcomes rather than the severity of the patient’s underlying illnesses.  (The limits of such risk adjustment have hindered the usefulness of hospital quality data reporting.)

Comparative Effectiveness
The recent stimulus legislation included $1.1 billion for comparative effectiveness research.  Greater federal funding in this area has raised concerns among some people in the medical research industry because this research could focus on comparing one medicine to another, or a medicine to a device, etc. without adequate risk adjustment in the research – and then be used by insurance companies and government agencies to make coverage and payment decisions.  And these concerns are legitimate because using such analysis and research for coverage decisions about medicines and devices has been done in countries such as England and Australia.

However, there is also an opportunity for comparative effectiveness research to be used to improve actual clinical practices by developing a broader array of checklists and other standardized protocols.  This is part of the promise of electronic medical records, since they can easliy incorporate such standardized guidelines into their formatting.  But from what I can tell, each brand and type of EMR/EHR has different standardizations and guidelines, and the way they display them can cause clinicians to quickly suffer from “alert fatigue,” so that eventually clinicians ignore all the suggestions and warnings – making them worse then nothing.

Aside from the technical issues of EMRs, the systemic challenge for successfully using comparative effectiveness to improve clinical care in this way is overcoming the resistance and fear of physicians. This factor almost ended the existence of the federal Agency for Healthcare Quality and Research, because its first major project, (when it was called the Agency for Health Care Policy and Research), found that surgery for low back pain was generally not indicated.  This conclusion caused such a reaction in the medical community that Congress almost stopped funding the entire agency.

Conclusions

  • Innovations that are being used in hospitals will be increasingly used in outpatient clinics and private practices.
  • These innovations will not only be technologies, such as diagnostic tests, but also methods of care, such as standardized checklists and protocols.
  • Using comparative effectiveness research to develop and validate the ability of such standardization to improve outcomes, will have greater effects on increasing quality of care and controlling costs than will research comparing different treatment options for individual diseases – even for very common and costly conditions like diabetes and CHF.  This will be true because even if such research shows which treatments are best, if clinicians aren’t following these recommendations in standardized ways, the value of this knowledge for patients and the healthcare system will be dramatically diminished.
  • Including physicians, other clinicians, and other stakeholders in the development and implementation of standardized practices will be critically important for their successful adoption and use – because as was seen in the dramatization in the ER episode, big personalities of individuals can overshadow, subvert or sidestep the proper use of standardized practices so that they may be followed in substance, but ignored in spirit.

Transparency & Accountability for Physicians in Health Reform

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Yesterday I had the opportunity to give Medical Grand Rounds at Caritas Carney Hospital in Boston on the topic of “Health Reform 2009 and Beyond.”  Rather than compare and contrast various national health reform proposals, I reviewed the major forces and trends that are reforming healthcare, and explained how they would likely impact different stakeholder groups – particularly physicians.

I started by discussing the major trends in cost, access and quality – noting how the first two are easier to quantify and that the debate over access to healthcare services versus insurance coverage has been resolved in favor of health insurance coverage, because only having access to free clinics and emergency rooms doesn’t enable people to get the type of healthcare that they really need.  The successor debate is what insurance needs to cover to be “adequate,” and what it means to be underinsured.

Transparency & Accountability
The heart of my talk was explaining the role of transparency and accountability in health reform at the national, state and private sector levels. (One of the earliest forms of transparency for clinicians was the National Practitioner Databank, which was created about 20 years ago to try and make it easier for the healthcare organization, insurers and government agencies to learn about adverse actions – such as malpractice suits and licensing board censures.)

“What are we getting for what we’re paying for?”
The most frequently discussed transparency initiative in healthcare is the big push for electronic health records. Information and transparency are being highly valued because as more detailed information about actual clinical and cost outcomes becomes available, it can be analyzed and used to make different parts of the healthcare system accountable for their contributions.  (Note: the apparent dramatic lack of transparency and accountability that contributed to the collapse and impairment of so many financial institutions has fueled public calls for more accountability and transparency in many parts of society – including healthcare.)

Capitation was an early attempt to place accountability for the cost outcomes of individual patients onto healthcare organizations.  However, because information connecting clinical decisions with overall costs was lacking, capitation was less than successful, and it often evolved into schemes to reduce the volume of care since that was the only measurement available related to total costs. Fortunately, accountability mechanisms have become more refined, and now include pay-for-performance, “episodes of care,  and other forms of bundling of payments.  (An example of an episode of care bundled payment would be a care group receiving a single payment amount for all the clinical services in a 30 day window for a patient receiving elective heart surgery.)

The common theme in this trend of transparency and accountability is that as costs continue to increase as a percentage of personal incomes, wages and GDP, insurance companies, private payers and employers, government agencies, and even patients are all asking, “what are we getting for what we’re paying?”

Power of the Pen
I also described for the physicians at Carney Hospital how as information systems become more sophisticated and can provide insights into the performance of smaller groups and individual physicians, more proposals and initiatives will seek to place greater accountability on the individual physicians because while physicians receive ~21% of all healthcare spending in this country, their actions influence how about 70-80% of each healthcare dollar is spent.

This concept is being translated into practice for Massachusetts state government employees, whose health benefits program has collecting and analyzing information about all the primary care physicians in the state, (and selected types of specialists), and then put them into three “quality tiers”: Excellent, Good, and Standard.  Accountability is added to this transparency because patients seeing physicians in the “higher quality” tiers pay lower insurance co-payments.

There is significant controversy around this profiling and tiering program – particularly about what data is used and how it is analyzed.  Certainly transparency and accountability are only valuable for creating positive changes when the data is valid and reliable – something I discussed with the physicians at Carney Hospital and have written about previously.  The key challenge in making this type of data valid and reliable is how adequately it is risk-adjusted in the analysis so that clinicians and providers are “graded” based upon their actual skill and work, rather than on the type of patients they see.

Medical Homes as Positive Solutions for Physicians
Another example of how the “power of the pen” concept is leading to new models for accountability in healthcare is the Medical Home.  I told the medical students, residents and attending physicians at Carney Hospital that Medical Homes might be a positive opportunity for physicians to improve the quality of care while accepting and managing more financial risk and responsibility.  Since the details of Medical Homes can be very complex, my one slide description was: “Medical Homes are arrangements where a physician (or group) is responsible for coordinating individual patient’s care across all sectors of the healthcare delivery system and ensuring that the patient receives appropriate preventive care and self-management assistance.”  Since financial compensation is often a concern for primary care physicians, I noted that payment for Medical Home services is in addition to reimbursement for traditional care services provided to patients, and it could be a flat (risk adjusted) payment per month per patient, while also including incentive payments for actually improving patients’ clinical outcomes and/or reducing the amount of healthcare spending they generated.

Challenges and Opportunities for Physicians
I concluded by noting that these changes present challenges and opportunities for physicians.  The first challenge is that if physicians don’t participate and lead in discussions about national policy issues and local delivery system reforms, then changes will be made to them rather than with them.  That is, they have the choice to “Lead or be Led.”

Such leadership also needs to be paired with collaboration – both within clinician communities and with other stakeholders such as administrators, employers, payers, government agencies and patients.  (These are two of the “lessons learned” from  Geisinger’s experience described by Paulus et. al., in their Health Affairs article last year.)  During the Grand Rounds’ Q&A it was also noted that geography and location are important factors influencing the ability of physicians and hospitals to exert leadership and promote collaboration within communities.  For example, Geisinger is the major healthcare delivery entity within a relatively contained geographic community. However, this observation illustrates the importance of multi-stakeholder collaboration, because without it, everyone is working in isolation, efforts are not coordinated, time and energy are wasted, and the outcomes provide little or no benefits to anyone.

Reviews & Outcomes
While the audience was attentive and only a few people left to answer pages, it is always hard to know how much a group benefits from this type of presentation. So I was very gratifying to receive this email review from one of the organizing physicians at the hospital:

“Thank you for the fabulous grand rounds at Caritas Carney Hospital yesterday.  You obviously put a great deal of time and thought into presenting to us; your lecture was a remarkable overview of so many issues affecting our health care system today! You have a great mind to be able to have both the comprehension to understand these concepts, and the ability to synthesize numerous trends and ideas into an integrated presentation. Two of the best compliments to you are 1) docs  stayed until the end of grand rounds and 2) our new insights inspired conversations and debates in hospital halls and offices all day long!” Mary Lou Ashur, M.D.

The last comment is precisely the outcome I was hoping to achieve, since just educating people about different proposals may not help build their understanding of the problems and possible solutions, not give them guidance for how they can get involved, etc.  And from the picture below taken after Grand Rounds, I think everyone was happy with the result – even if I do have a funny smile.

Grand Rounds - Carney Hospital -031109